Exelixis’ Collaborator Daiichi Sankyo Launches MINNEBRO® (Esaxerenone) Tablets in Japan
13 May 2019 - 8:00PM
Business Wire
-- First commercial sale triggers $20
million milestone payment to Exelixis --
Exelixis, Inc. (Nasdaq: EXEL) today announced its partner
Daiichi Sankyo Company, Limited (“Daiichi Sankyo”) has launched
MINNEBRO® (esaxerenone) tablets as a treatment for patients with
hypertension in Japan. With Daiichi Sankyo’s first commercial sale
of MINNEBRO, Exelixis will receive an associated $20 million
milestone payment from Daiichi Sankyo under the terms of the
companies’ collaboration agreement. Exelixis anticipates receiving
the payment during the second quarter of 2019.
“Daiichi Sankyo’s launch of MINNEBRO in Japan is an important
advance for patients with hypertension in Japan, as well as for our
two companies,” said Michael M. Morrissey, Ph.D., President and
Chief Executive Officer of Exelixis. “We congratulate Daiichi
Sankyo on this milestone and look forward to the company’s further
progress in MINNEBRO’s clinical development and
commercialization.”
MINNEBRO is a novel mineralocorticoid receptor blocker
identified during the prior research collaboration between Exelixis
and Daiichi Sankyo and subsequently developed and commercialized by
Daiichi Sankyo. The companies entered into their research
collaboration in March 2006. MINNEBRO’s regulatory application
acceptance in Japan in the first quarter of 2018 triggered a
previous $20 million milestone payment, and Exelixis remains
eligible for substantial commercialization milestones, as well as
low double-digit royalties on MINNEBRO sales. Daiichi Sankyo is
also conducting an ongoing phase 3 trial of esaxerenone in patients
with diabetic nephropathy in Japan (ESAX-DN).
About MINNEBRO® (Esaxerenone) Tablets
MINNEBRO® (Esaxerenone) tablets (1.25 mg, 2.5 mg and 5 mg) are
approved by the Japanese Ministry of Health, Labour, and Welfare as
a treatment for patients with hypertension in Japan. The
application for approval was submitted in Japan in February 2018 on
the basis of results that included data from a phase 3 clinical
trial conducted in Japan (ESAX-HTN study) in patients with
essential hypertension. Excessive mineralocorticoid receptor (MR)
activation has been found to be involved in hypertension, and
MINNEBRO is considered to exert an antihypertensive effect by
blocking this receptor activation.
About Hypertension in Japan
According to the 2012 Japan National Health and Nutrition
Survey, there are an estimated 43 million patients with
hypertension in the country, which accounts for 60 percent of men
and 45 percent of women over the age of 30 in the general Japanese
population.1 Only approximately 30 percent of men and 40 percent of
women with hypertension who are treated with antihypertensive
medication typically achieve the goal of systolic and diastolic
blood pressure lower than 140/90mm Hg.
Hypertension is one of the major risk factors for cardiovascular
disease, such as stroke and coronary heart disease, and the
condition also raises the risk of chronic kidney disease and
end-stage renal disease.1 Essential hypertension is the most common
form of hypertension, affecting 90 percent of hypertensive
patients, and is associated with heterogeneous contributory factors
such as genetics and lifestyle habits, while secondary hypertension
is associated with identified underlying disease factors.1
About Exelixis
Founded in 1994, Exelixis, Inc. (Nasdaq: EXEL) is a commercially
successful, oncology-focused biotechnology company that strives to
accelerate the discovery, development and commercialization of new
medicines for difficult-to-treat cancers. Following early work in
model genetic systems, we established a broad drug discovery and
development platform that has served as the foundation for our
continued efforts to bring new cancer therapies to patients in
need. Our discovery efforts have resulted in four marketed
products, CABOMETYX® (cabozantinib), COMETRIQ® (cabozantinib),
COTELLIC® (cobimetinib) and MINNEBRO® (esaxerenone), and we have
entered into partnerships with leading pharmaceutical companies to
bring these important medicines to patients worldwide. Supported by
revenues from our marketed products and collaborations, we are
committed to prudently reinvesting in our business to maximize the
potential of our pipeline. We are supplementing our existing
therapeutic assets with targeted business development activities
and internal drug discovery - all to deliver the next generation of
Exelixis medicines and help patients recover stronger and live
longer. Exelixis is a member of Standard & Poor’s (S&P)
MidCap 400 index, which measures the performance of profitable
mid-sized companies. For more information about Exelixis, please
visit www.exelixis.com, follow @ExelixisInc on Twitter or
like Exelixis, Inc. on Facebook.
Forward-Looking Statements
This press release contains forward-looking statements,
including, without limitation, statements related to: the
anticipated timing for receipt of a $20 million milestone
payment from Daiichi Sankyo associated with the first
commercial sale of MINNEBRO in Japan; the potential for
further progress in MINNEBRO’s clinical development and
commercialization; Exelixis’ eligibility for substantial
commercialization milestones as well as low double-digit royalties
on the sale of MINNEBRO; and Exelixis’ plans to reinvest in its
business to maximize the potential of the company’s pipeline,
including through targeted business development activities and
internal drug discovery. Any statements that refer to expectations,
projections or other characterizations of future events or
circumstances are forward-looking statements and are based upon
Exelixis’ current plans, assumptions, beliefs, expectations,
estimates and projections. Forward-looking statements involve risks
and uncertainties. Actual results and the timing of events could
differ materially from those anticipated in the forward-looking
statements as a result of these risks and uncertainties, which
include, without limitation: the degree of market acceptance of
MINNEBRO in the territories where it is approved, and Daiichi
Sankyo’s ability to obtain or maintain coverage and reimbursement
for this product; Exelixis’ dependence on its relationship
with Daiichi Sankyo, including Daiichi Sankyo’s investment in
the resources necessary to successfully commercialize MINNEBRO in
the territories where it is approved; market competition, including
the potential for competitors to obtain approval for generic
versions of MINNEBRO; Exelixis’ and Daiichi Sankyo’s continuing
compliance with applicable legal and regulatory requirements;
Exelixis’ and Daiichi Sankyo’s ability to protect their respective
intellectual property rights; changes in economic and business
conditions; and other factors affecting Exelixis and its
partnerships discussed under the caption “Risk Factors” in
Exelixis’ Quarterly Report on Form 10-Q filed with
the Securities and Exchange Commission (SEC) on May
1, 2019, and in Exelixis’ future filings with the SEC. All
forward-looking statements in this press release are based on
information available to Exelixis as of the date of this
press release, and Exelixis undertakes no obligation to
update or revise any forward-looking statements contained
herein.
Exelixis, the Exelixis logo,
CABOMETYX, COMETRIQ and COTELLIC are registered U.S. trademarks.
MINNEBRO is a registered Japanese trademark.
References
1 The Japanese Society of Hypertension Guidelines for the
Management of Hypertension (JSH 2014). Hypertens
Research 2014; 37: 253-392.
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version on businesswire.com: https://www.businesswire.com/news/home/20190513005252/en/
Investors Contact:Susan HubbardEVP,
Public Affairs & Investor RelationsExelixis,
Inc.650-837-8194shubbard@exelixis.com
Media Contact:Hal MackinsFor Exelixis,
Inc.415-994-0040hal@torchcommunications.com
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